Actively Recruiting
Investigating New Front-end Features in the SONNET 3 Cochlear Implant Audio Processor to Improve Hearing in Noise
Led by MED-EL Elektromedizinische Geräte GesmbH · Updated on 2026-04-23
40
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
M
MED-EL Elektromedizinische Geräte GesmbH
Lead Sponsor
M
Medizinische Universität Innsbruck, Universitätsklinik für Hör-, Stimm-, und Sprachstörungen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying cochlear implant users with severe to profound sensory-neural hearing loss who have experienced MED-EL cochlear implants for at least six months. The study evaluates new front-end features for the MED-EL SONNET 3 audio processor, aiming to improve hearing in noisy environments by using advanced signal-processing methods, including a Focused Beamformer to enhance directional hearing and an AI Mode Medium for adaptive sound processing. Participants will test new front-end features compared to the approved beamformer and AI mode in a within-subject design. Each subject will be fitted with a MED-EL SONNET 3 audio processor, and the study focuses on comparing these technologies to see how well they work for hearing in background noise. During the study, participants' speech recognition in noise will be assessed immediately after the intervention using the Oldenburg Sentence Test. Researchers will monitor how the new features affect hearing performance and safety. The total duration and specific visit schedules are not detailed, but assessments focus on speech understanding in noisy conditions after using the new audio processor features.
CONDITIONS
Brief Title
This Clinical Investigation Assesses the Safety and Performance of a New Beamformer for MED-EL Cochlear Implant Recipients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Minimum age of eighteen (18) years at time of enrolment
- Experienced MED-EL cochlear implant user for the ear to be tested for at least 6 months
- Current user of a MED-EL Audio Processor (SONNET, SONNET 2, SONNET 3, or RONDO 3) for at least 3 months
- Post-lingual onset of severe to profound sensory-neural hearing loss on the ear to be tested
- Minimum of 40% speech recognition in the Freiburg Monosyllables Test in quiet at 65 dB SPL for the ear to be tested
- Signed and dated Informed Consent Form before any study procedures
You will not qualify if you...
- Lack of compliance with any inclusion criteria
- Contralateral hearing equal to or better than 30 dB (pure-tone average at 250, 500, 1000, and 2000 Hz)
- Implanted with C40X or C40C on the ear to be tested
- Implanted with an auditory brainstem implant or Split electrode array
- Known allergic reactions to components of the investigational medical device
- Any condition that increases risk or prevents full compliance as judged by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration as per intervention period
Participants are fitted with a MED-EL SONNET 3 audio processor and test new front-end features, including the Focused Beamformer and AI Mode Medium, compared to approved features in a within-subject design.
Trial Site Locations
Total: 2 locations
1
Medizinische Universität Innsbruck, Universitätsklinik für Hör-, Stimm-, und Sprachstörungen
Innsbruck, Austria
Actively Recruiting
2
Universitätsklinikum St. Pölten, Abteilung für Hals-, Nasen- und Ohrenerkrankungen
Sankt Pölten, Austria
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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